FDA.reportPublic FDA data

Hydroxychloroquine Sulfate

Product NDC
83980-001
11-digit product format
839800001
Labeler code
83980
Product ID
83980-001_31f4188d-1c26-4aab-aa12-354329160a39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxychloroquine Sulfate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ipca Laboratories Limited
Application
ANDA040766
Marketing category
ANDA
Marketing start
2024-06-03
Substance
HYDROXYCHLOROQUINE SULFATE
Active strength
200 mg/1
Pharmacologic classes
Antimalarial [EPC], Antirheumatic Agent [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroxychloroquine Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYCHLOROQUINE SULFATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8Q2869CNVH
Rxcui979092

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
476a7bfa-95aa-4caa-a32b-b0e157b2cc83Product name120220928
79a2ab33-ef76-b1c3-49e7-8533315e153bProduct name520200716
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83980-001-01Hydroxychloroquine Sulfate100 in 1 BOTTLETABLET, FILM COATED1003
83980-001-05Hydroxychloroquine Sulfate500 in 1 BOTTLETABLET, FILM COATED5003
83980-001-10Hydroxychloroquine Sulfate1000 in 1 BOTTLETABLET, FILM COATED10003
83980-001-97Hydroxychloroquine Sulfate10 in 1 BOTTLETABLET, FILM COATED103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83980-001-01EA - Each83980-0017b0a807f-184d-476f-bc30-8f14444716e712024-07-12
83980-001-05EA - Each83980-001a5b41f16-13fb-4cae-a29f-321c0d254ba612024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83980-001HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [IPCA LABORATORIES LIMITED]3Current NDC, 4 package rows20241121_9dfa0ff8-e8cf-47f9-847a-b86f23dc39df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN9dfa0ff8-e8cf-47f9-847a-b86f23dc39df3
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD9dfa0ff8-e8cf-47f9-847a-b86f23dc39df3
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY9dfa0ff8-e8cf-47f9-847a-b86f23dc39df3
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN2eeaf562-95f9-bcef-e063-6394a90a1c191
979092hydroxychloroquine sulfate 200 MG Oral TabletPSN37413f6b-fb68-4e0c-8bcc-c5b76e956dfc1
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD2eeaf562-95f9-bcef-e063-6394a90a1c191
979092hydroxychloroquine sulfate 200 MG Oral TabletSCD37413f6b-fb68-4e0c-8bcc-c5b76e956dfc1
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY2eeaf562-95f9-bcef-e063-6394a90a1c191
979092hydroxychloroquine sulfate 200 MG (as hydroxychloroquine 155 MG) Oral TabletSY37413f6b-fb68-4e0c-8bcc-c5b76e956dfc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83980-001-0183980000101100 TABLET, FILM COATED in 1 BOTTLE (83980-001-01) 2024-06-03NoNoCurrent
83980-001-0583980000105500 TABLET, FILM COATED in 1 BOTTLE (83980-001-05) 2024-06-03NoNoCurrent
83980-001-10839800001101000 TABLET, FILM COATED in 1 BOTTLE (83980-001-10) 2024-06-03NoNoCurrent
83980-001-978398000019710 TABLET, FILM COATED in 1 BOTTLE (83980-001-97) 2024-06-03NoNoCurrent